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Ranibizumab and bevacizumab for neovascular age-related macular degeneration.

Publication ,  Journal Article
CATT Research Group, ; Martin, DF; Maguire, MG; Ying, G-S; Grunwald, JE; Fine, SL; Jaffe, GJ
Published in: N Engl J Med
May 19, 2011

BACKGROUND: Clinical trials have established the efficacy of ranibizumab for the treatment of neovascular age-related macular degeneration (AMD). In addition, bevacizumab is used off-label to treat AMD, despite the absence of similar supporting data. METHODS: In a multicenter, single-blind, noninferiority trial, we randomly assigned 1208 patients with neovascular AMD to receive intravitreal injections of ranibizumab or bevacizumab on either a monthly schedule or as needed with monthly evaluation. The primary outcome was the mean change in visual acuity at 1 year, with a noninferiority limit of 5 letters on the eye chart. RESULTS: Bevacizumab administered monthly was equivalent to ranibizumab administered monthly, with 8.0 and 8.5 letters gained, respectively. Bevacizumab administered as needed was equivalent to ranibizumab as needed, with 5.9 and 6.8 letters gained, respectively. Ranibizumab as needed was equivalent to monthly ranibizumab, although the comparison between bevacizumab as needed and monthly bevacizumab was inconclusive. The mean decrease in central retinal thickness was greater in the ranibizumab-monthly group (196 μm) than in the other groups (152 to 168 μm, P=0.03 by analysis of variance). Rates of death, myocardial infarction, and stroke were similar for patients receiving either bevacizumab or ranibizumab (P>0.20). The proportion of patients with serious systemic adverse events (primarily hospitalizations) was higher with bevacizumab than with ranibizumab (24.1% vs. 19.0%; risk ratio, 1.29; 95% confidence interval, 1.01 to 1.66), with excess events broadly distributed in disease categories not identified in previous studies as areas of concern. CONCLUSIONS: At 1 year, bevacizumab and ranibizumab had equivalent effects on visual acuity when administered according to the same schedule. Ranibizumab given as needed with monthly evaluation had effects on vision that were equivalent to those of ranibizumab administered monthly. Differences in rates of serious adverse events require further study. (Funded by the National Eye Institute; ClinicalTrials.gov number, NCT00593450.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 19, 2011

Volume

364

Issue

20

Start / End Page

1897 / 1908

Location

United States

Related Subject Headings

  • Visual Acuity
  • Therapeutic Equivalency
  • Single-Blind Method
  • Retina
  • Ranibizumab
  • Proportional Hazards Models
  • Off-Label Use
  • Middle Aged
  • Male
  • Macular Degeneration
 

Citation

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CATT Research Group, ., Martin, D. F., Maguire, M. G., Ying, G.-S., Grunwald, J. E., Fine, S. L., & Jaffe, G. J. (2011). Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med, 364(20), 1897–1908. https://doi.org/10.1056/NEJMoa1102673
CATT Research Group, Glenn J., Daniel F. Martin, Maureen G. Maguire, Gui-shuang Ying, Juan E. Grunwald, Stuart L. Fine, and Glenn J. Jaffe. “Ranibizumab and bevacizumab for neovascular age-related macular degeneration.N Engl J Med 364, no. 20 (May 19, 2011): 1897–1908. https://doi.org/10.1056/NEJMoa1102673.
CATT Research Group, Martin DF, Maguire MG, Ying G-S, Grunwald JE, Fine SL, et al. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med. 2011 May 19;364(20):1897–908.
CATT Research Group, Glenn J., et al. “Ranibizumab and bevacizumab for neovascular age-related macular degeneration.N Engl J Med, vol. 364, no. 20, May 2011, pp. 1897–908. Pubmed, doi:10.1056/NEJMoa1102673.
CATT Research Group, Martin DF, Maguire MG, Ying G-S, Grunwald JE, Fine SL, Jaffe GJ. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med. 2011 May 19;364(20):1897–1908.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 19, 2011

Volume

364

Issue

20

Start / End Page

1897 / 1908

Location

United States

Related Subject Headings

  • Visual Acuity
  • Therapeutic Equivalency
  • Single-Blind Method
  • Retina
  • Ranibizumab
  • Proportional Hazards Models
  • Off-Label Use
  • Middle Aged
  • Male
  • Macular Degeneration